Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.

Summary

Hypothesis: ITB bolus can have antinociceptive effect on neuropathic pain in spinal cord injury patients, which could depend on the subtype of pain, or on the lesion level, cervical or thoracic spinal cord injury. Objective: To study the effect of intrathecal baclofen bolus on neuropathic pain in patients with spinal cord injury at cervico-dorsal level. Primary Endpoint: Effect of intrathecal baclofen bolus in neuropathic pain (measured using the Neuropathic Pain Inventory Scale, the Brief Pain Inventory and the Numerical Rating Scale) in spinal cord injury at cervico-dorsal level. Secondary Endpoints: 1. Spasticity and spasms (measured using the Modified Ashworth Scale and the Visual Analogue Scale and Penn Spasm Frequency Scale). 2. Neurophysiological examination (warm perception threshold, heat pain perception threshold, evoked pain perception and contact heat evoked potentials).

Timeline

Start

2014-12

Primary completion

2017-08

Completion

2017-08

Drugs

Indications